FLORA™: Phase I development of a functional vision assessment for prosthetic vision users.

FLORA™: Phase I development of a functional vision assessment for prosthetic vision users.
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Flora™:第一阶段开发针对假肢视觉用户的功能视觉评估。

DOI:
10.1111/cxo.12242
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发表时间:
2015-07
影响因子:
1.9
通讯作者:
Dorn J
Dorn J
中科院分区:
医学4区
文献类型:
--
作者:
Geruschat DR;Flax M;Tanna N;Bianchi M;Fisher A;Goldschmidt M;Fisher L;Dagnelie G;Deremeik J;Smith A;Anaflous F;Dorn J

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研究小组和资助机构需要适合超低视力人群的功能评估,以评估新的视力恢复治疗的影响。本研究的目的是开展一项试点评估,以了解通过 Argus II 视网膜假体系统部分恢复视力的受试者的功能性视力和健康状况。功能性低视力观察者评级(FLORA)试点评估包括自我报告部分、用于观察表现的功能性视力任务列表以及案例叙述摘要。对结果进行分析,以确定访谈问题和功能性视力任务是否适合这种超低视力人群,以及评分是否受到下限或上限效应的影响。 30 名患有严重至深度色素性视网膜炎(双眼裸光感或更差)的受试者参加了一项临床试验,并植入了 Argus II 系统。从这个人群中,有 26 名受试者接受了 FLORA 评估。七名不同的评估员进行了评估。 14 个面试问题全部被问到。所有 35 项功能性视觉任务均被选择至少进行一次评估,每个测试项目平均评估 20 名受试者。评估者使用了所有四种评级选项——不可能(33%)、困难(23%)、中等(24%)和简单(19%)。评估人员还判断了他们观察受试者完成各种任务时使用的视力量,系统开启时视力平均只有 75%,系统关闭时视力平均只有 29%。人们发现 FLORA 的第一个版本包含用于评估和避免地板和天花板效应的有用元素。下一阶段的开发将是完善评估并建立可靠性和有效性,以提高其作为功能愿景和福祉评估工具的价值。
Research groups and funding agencies need a functional assessment suitable for an ultra-low vision population in order to evaluate the impact of new vision restoration treatments. The purpose of this study was to develop a pilot assessment to capture the functional vision ability and well-being of subjects whose vision has been partially restored with the Argus II Retinal Prosthesis System. The Functional Low-Vision Observer Rated Assessment (FLORA) pilot assessment involved a self-report section, a list of functional vision tasks for observation of performance, and a case narrative summary. Results were analyzed to determine whether the interview questions and functional vision tasks were appropriate for this ultra-low vision population and whether the ratings suffered from floor or ceiling effects. Thirty subjects with severe to profound retinitis pigmentosa (bare light perception or worse in both eyes) were enrolled in a clinical trial and implanted with the Argus II System. From this population, twenty-six subjects were assessed with the FLORA. Seven different evaluators administered the assessment. All 14 interview questions were asked. All 35 functional vision tasks were selected for evaluation at least once, with an average of 20 subjects being evaluated for each test item. All four rating options -- impossible (33%), difficult (23%), moderate (24%) and easy (19%) -- were used by the evaluators. Evaluators also judged the amount of vision they observed the subjects using to complete the various tasks, with vision only occurring 75% on average with the System ON, and 29% with the System OFF. The first version of the FLORA was found to contain useful elements for evaluation and to avoid floor and ceiling effects. The next phase of development will be to refine the assessment and to establish reliability and validity to increase its value as a functional vision and well-being assessment tool.
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